5MP GRAYSCALE LCD DISPLAY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K132610". Below that, the text reads "Page 1 of 1". At the bottom, the text reads "510(k) Submission". # 510(k) Summary [As required by 21 CFR 807.92] # 1. Date Prepared [21 CFR807.92 (a) (1)] December 24, 2012 # 2. Submitter's Information [21 CFR807.92 (a) (1)] | Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd | |------------------|--------------------------------------------------------------------------------------------------------------| | Address: | Room 201, Incubator Building, CASTD, High-tech South 1st<br>street, Nanshan District, Shenzhen 518057, China | | Contact Name: | Wu Qin | | Telephone No.: | +86 755 26995355 | | Fax No.: | +86 755 26995755 | | Email Address: | wuqin@beacon-display.cn | ### 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)] | Trade Name: | 5MP Grayscale LCD Display | |-----------------------|-------------------------------------------------------| | Common Name: | Display system, medical image workstation, and others | | Classification: | 892.2050 system, image processing, radiological | | Product code: | LLZ | | Classification Panel: | Radiology | | Device Class: | II | ## 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] The identified predicates within this submission are as follows: Barcoview, Nio 5MP-21" has been cleared by FDA through 510(k) No.K062621 (Decision Date -Mar 19, 2007), {1}------------------------------------------------ ### 5. Description of the Device [21 CFR 807.92(a) (4)] The G52SP+/G52S+ 5MP Grayscale LCD display is a display system for medical viewing, with high resolution 2560 x 2048, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier. # 6. Intended Use [21 CFR 807.92(a)(5)] The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. | Panel | 21.3", TFT monochrome LCD screen, antigalre | |-----------------------|--------------------------------------------------------| | Brightness (typ.) | 1200 cd/m² | | CR (typ.) | 1200:1 | | Viewing angle | R/L 170°, U/D 170° Typ. (CR > 20) | | Pixel Pitch | 0.165 mm | | Native resolution | 2560 x 2048 | | Display area | 422.4mm(H)x337.92mm (V) | | Compatible video | 640 x 480@60Hz(progressive) | | signals | 2560 x 2048@50Hz(progressive) | | Horizontal resolution | 2560 x 2048 | | Bandwidth | <300MHz | | Aspect ratio | 5:4 | | Screen size | 21.3" real diagonal | | Power | DC12V/5.0A | | Power consumption | Max. 80 W | | Input signals | DVI-D, Display Port | | Digital input | TMDS (single) | | Plug and play | VESA DDC 2B | | Dimension | 398.5mm (W) x 483.0mm (H) x 70.8mm (D) (without Stand) | | | 398.5 mm (W) x 629.6 mm (H) x 234.8mm (D) (with Stand) | ### 7. Technological Characteristics [21 CFR 807.92(a)(6)] 510(k) Summary {2}------------------------------------------------ | Weight | 7.5kg (without Stand)<br>11.2kg (with Stand) | |-------------------------------------|------------------------------------------------| | Operating temperature and humidity: | Temperature: 0°C ~ 40°C<br>Humidity: 15%~85% | | Storage temperature and humidity: | Temperature: -20°C ~ 60°C<br>Humidity: 10%~90% | # 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92] ### 8.1 Intended uses: #### Table 1 Intended Use Comparison | ID | Comparison<br>Item | Proposed Device<br>G52SP+/G52S+ | Predicate Device<br>Nio 5MP-21 | |----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Intended<br>Use | The G52SP+/G52S+<br>5MP Grayscale LCD<br>Display is intended to be<br>used in displaying and<br>viewing digital images,<br>including digital<br>mammography, for<br>review and analysis by<br>trained medical<br>practitioners. | "The Nio 5MP-21" is intended to be<br>used in displaying and viewing digital<br>images, including digital<br>mammography, for review and<br>analysis by trained medical<br>practitioners. The Nio 5MP- 21",<br>containing the display MDNG-5121<br>CB, the software NioWatch and the<br>graphic board BarcoMed Nio, will be<br>marketed as separate device. | # 8.2 Comparison table #### Table 2 General Comparison | ID | Comparison<br>Item | Proposed Device<br>G52SP+/G52S+ | Predicate Device<br>Nio 5MP-21 | |-------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2 | Performance | | | | 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display | | 2.2 | Pixel Pitch | 0.165 mm | 0.165 mm | | 2.3 | Available Cabinet<br>Colors | Black | Black | | 2.4 | Native Resolutions | 2560×2048 | 2560×2048 | | 2.5 | Brightness | 1200 cd/m2 | 700 cd/m2 | | 2.6 | Contrast Ratio | 1200:1 | 800:1 | | 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) | | 2.8 | Active Display Size | 422mm x338mm(HxV) | 422mm x338mm(HxV) | | | Comparison<br>Item | Proposed Device<br>G52SP+/G52S+ | Predicate Device<br>Nio 5MP-21 | | ID | | | | | 3 | Physical Specifications | | | | 3.1 | Dimensions<br>(Wx Hx D) | 398.5mm (W) x 483.0mm (H)<br>x 70.8mm (D) (without Stand)<br><br>398.5 mm (W) x 629.6 mm (H)<br>x 234.8mm (D) (with Stand) | 382mm x 488mm x 114mm<br>(without Stand)<br>Portrait:<br>408mm x 489~549mm<br>x 250mm<br>Landscape:<br>492mm x 531~591mm<br>x 250mm<br>(with Stand) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C | | 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C | | Relative humidity | | | | | 3.4 | Operating | 15% ~85% | 8% ~80%(non-condensing) | | 3.5 | Transport/ Storage | 10% ~90% | 5% ~95% | | 4 | Power Supply | | | | 4.1 | PowerCapacity | <80W | 95W | | 4.2 | Input Voltage | DC12V/5.0A | 100~250v | | 5 | Human factors (operation characteristic) | | | | 5.1 | Usability | Button operation,<br>LED indicator | Button operation,<br>LED indicator | | 5.2 | Mode of operation | Continuous operation | Continuous operation | | 6 | Biocompatibility | | | | 6.1 | Evaluation | The proposed device does not<br>contain any components.that<br>come into direct or indirect<br>contact with patients, so the<br>evaluation doesn'tbe needed. | The proposed device does<br>not contain any components<br>that come into direct or<br>indirect contact with patients,<br>so the evaluation doesn't be<br>needed. | | 7 | Sterility | | | | 7.1 | Sterilization | The proposed device does not<br>need sterilization. | The proposed device does<br>not need sterilization. | | 8 | Electrical & Mechanical safety& Thermal safety | | | | 8.1 | Type of protection<br>against electric<br>shock | Class I | Class I | | 8.2 | Degree of protection<br>against harmful<br>ingress of liquid | Ordinary equipment. | Ordinary equipment. | | 8.3 | Evaluation | The electrical, mechanical and | The electrical, mechanical and | | ID | Comparison<br>Item | Proposed Device<br>G52SP+/G52S+ | Predicate Device<br>Nio 5MP-21 | | | | thermal safety evaluation is<br>conducted as per the<br>requirements of the standard<br>IEC 60601-1. | and thermal safety evaluation<br>is conducted as per the<br>requirements of the standard<br>IEC 60601-1. | | 9 | Electromagnetic Compatibility | | | | 9.1 | EMC Evaluation | Complying with<br>IEC 60601-1-2 | Complying with<br>IEC 60601-1-2 | {3}------------------------------------------------ : . ' . {4}------------------------------------------------ #### 8.4 Discussion of Differences: It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE). Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected. Review of ID 2 - Performance, except two items as below, both are the same, so the SE is not affected. - 1. Brightness. The proposed device is 1200 cd/m² and the predicate device is 700 cd/m², but the 1200 cd/m² is better than 700 cd/m² in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected. - 2. Contrast Ratio, The proposed device is 1200:1 and the predicate device is 800:1, but the 1200:1 is better than 800:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected. Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected. Review of ID 5 - Human factors, both are the same, so the SE is not affected. Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected. Review of ID 7 - Sterility, both are the same, so the SE is not affected. 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows handwritten text on a white background. The text includes "K1326.10" on the first line and "Page 6 of 6" on the second line. Below this, the words "510(k) Submission" are printed in a smaller font. Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected. Review of ID 9 - EMC, both are the same, so the SE is not affected. ## 9. Conclusion [21 CFR 807.92(b) (3)] In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd concludes that G52SP+/G52S+ 5MP Grayscale LCD display is substantially equivalent to predicate devices with regard to safety and effectiveness. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drun Administration 10903 New Hampshire Avenue Document Control Center - WOGG-GOOD Silver Spring, MD 20993-0002 September 4, 2013 Shenzhen Beacon Display Technology Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, I.I.C. 1394 25th Street NW BUFFALO MN 55313 . Re: K132610 Trade/Device Name: G52SP+/G52S+ 5MP Grayscale LCD Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: Ll.Z. Dated: August 19, 2013 Received: August 20, 2013 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. lf your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practive requirements as set {7}------------------------------------------------ Page 2-Mr. Job forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default,htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours,  for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K132610 Device Name: G52SP+/G52S+ 5MP Grayscale LCD Display Indications for Use: The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Smh.7) (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K132610 Page 1 of 1